A Study to Evaluate CM336 in Adults With Autoimmune Bullous Disease

An Open-label, PhaseⅡ Study to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults With Moderate to Severe Autoimmune Bullous Disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06900010

Enrollment

Registered

2025-03-28

Start date

2025-04-22

Completion date

2028-01-01

Last updated

2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Bullous Disease

Brief summary

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease

Detailed description

This study will set up two cohorts, Cohort 1: Patients with pemphigus, and plan to enroll approximately 20 adults with pemphigus; and Cohort 2: patients with bullous pemphigoid, and plan to enroll approximately 10 adults with bullous pemphigoid. Cohort 1 is divided into Part 1 and Part 2: Part 1 is planned to enroll approximately 10 subjects with pemphigus who had an inadequate response to prior corticosteroid therapy or whose disease uncontrolled despite high-dose corticosteroids. Part 2 is planned to enroll approximately 10 subjects with pemphigus who had an inadequate response to anti-CD20 monoclonal antibody therapy.

Interventions

BIOLOGICALCM336 Injection

subcutaneous CM336 administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 1\. Confirmed diagnosis of autoimmune bullous disease； * 2\. Age ≥18 years, regardless of gender； * 3\. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.

Exclusion criteria

* 1\. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation； * 2\. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy； * 3\. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336； * 4\. Any other condition deemed by the investigator to render the subject unsuitable for study participation.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the efficacy after CM336 treatment	Up to 52 weeks	Proportion of subjects in sustained complete remission

Countries

China

Contacts

CONTACTFuren Zhang

splcsy@126.com15854179852

PRINCIPAL_INVESTIGATORFuren Zhang

Dermatology Hospital affiliated to Shandong First Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026